Dilaudid

In shortageOrange BookUNIISPLATC N02AA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeN02AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7604512111
10 SYRINGE in 1 CARTON (76045-121-11) / 1 mL in 1 SYRINGE (76045-121-01)

Annotations

UNII (FDA Substance ID)

L960UP2KRW

HYDROMORPHONE HYDROCHLORIDE

RxCUI 203177

Orange Book

N019034

APAPAPAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Hydromorphone Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "L960UP2KRW",
    "rxcui": "203177",
    "inchikey": "XHILEZUETWRSHC-NRGUFEMZSA-N",
    "display_name": "HYDROMORPHONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "d6b40e39-a57e-402c-b4f6-7041e832f837": {
      "match": "brand_token",
      "title": "DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET DILAUDID (HYDROMORPHONE HYDROCHLORIDE) SOLUTION [RHODES PHARMACEUTICALS LLC]",
      "spl_version": "12",
      "published_date": "2026-05-20"
    }
  },
  "productid": "76045-121_97bfcafb-2037-47dc-a0ae-f7b8007c47df",
  "productndc": "76045-121",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019034",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Jan 11, 1984"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG/VIAL",
        "product_no": "002",
        "approval_date": "Aug 4, 1994"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "003",
        "approval_date": "Apr 30, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "004",
        "approval_date": "Apr 30, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "4MG/ML",
        "product_no": "005",
        "approval_date": "Apr 30, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.2MG/ML",
        "product_no": "006",
        "approval_date": "Jan 16, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5MG/0.5ML",
        "product_no": "007",
        "approval_date": "Feb 10, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROMORPHONE HYDROCHLORIDE",
  "shortage_reason": "Hydromorphone Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Dilaudid",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019034",
  "marketing_category": "NDA",
  "nonproprietary_name": "Hydromorphone hydrochloride",
  "start_marketing_date": "20161216",
  "active_numerator_strength": ".2"
}

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